Standardization is an integral step in improving the clinical trial design and build process. In addition, organizations are looking to leverage technology solutions to effectively manage and automate metadata processes. But what are the driving factors, challenges and important considerations for those looking to modernize their approach to clinical trial design and build?
In this webinar, Formedix explores these considerations and discusses the role of metadata standardization in end-to-end trial design. Alongside the vendor perspective, participants will hear real-world insights from global biopharmaceutical company UCB. Panelists will share their experience and ongoing journey to achieve standardization – in particular, the role of technology in achieving metadata automation. Participants will benefit from UCB’s first-hand experience, including effective strategies, avoiding the pitfalls and best practices for driving standardization through a clinical metadata repository (MDR).
Register for this webinar to learn about:
- The business case for change – time to modernize legacy systems and processes to drive operational improvements
- Change management – the automated study concept
- How to achieve reuse and standards compliance in clinical trial design and build
- Essential considerations for a successful clinical metadata repository (MDR)
- Practical implementation – culture and mindset change
- The challenges you’re likely to face and how to navigate them
- How APIs can be used to maximize standardized content
Gilbert Hunter, Customer Success Manager, Formedix
Gilbert joined Formedix over seven years ago as a Technical Writer. Four years ago, the knowledge gained from content development together with his customer service skills marked him out for transition to the Professional Services Team.
In his current role, Gilbert provides CDISC and software training, support and consultancy services to Pharmaceutical, Biotechnology and CRO organisations. He helps them save time and money by making their clinical trial design and regulatory submissions more efficient.
Stayce Murray, Head of IT, Digital Clinical Development, UCB
Stayce has a passion for bringing differentiated solutions to patient’s lives. With over 20 years’ experience, she has fueled that passion by continually asking, “is there a better way?”. When asking that question, Stayce often challenges others to ‘dream big’ and not constrain themselves to what is known and in place. She likes to catch those dreams and transform them into reality. That desire for transformation is ever-present in her dedication and aspirations for an end-to-end clinical environment. Through collaboration, incremental advancements and an open mindset, Stayce has helped lead this vision and practical implementation that will ensure the dream of end-to-end becomes a reality.
Cindy Stroupe, Senior Principal Statistical Programmer, UCB
Cindy Stroupe has been at UCB Biosciences, Inc. for 17 years. She is the Standards Lead for ADaM and TFLs within the Statistical Sciences and Innovation group. Cindy was the lead author on UCB’s internal ADaM Interpretation Guide and ADaM Integration Guide and drives implementation of CDISC standards for studies and submissions worldwide. She has worked in the industry for 22 years. Cindy is also the designated unicorn keeper for UCB.
Who Should Attend?
This webinar will benefit those responsible for or involved in standardization in clinical trials. This includes people working on data standards, data management, regulatory compliance (including CDISC) and governance in pharmas, biotechs, CROs and healthcare organizations. Relevant areas of expertise and job titles include:
- Regulatory Affairs
- Clinical Operations
- Clinical Affairs
- Project Management
- VP/Director of Data Standards or Data Management
- Executive/Associate Director of Data Standards or Data Management
- Head of Data Standards or Data Management
- Data or Data Standards Manager/Associate Manager
- Clinical Data Associate
- Team Leader of Data Standards or Data Management
- Data Manager/Clinical Data Manager
- Data Standards or Data Management Specialist
- VP or Director of Biostatistics / Biometrics / Statistical Programming
- Manager or Head of Biometrics / Biostatistics / Statistical Programming
- Biostatistician / Biometrician / Statistical Programmer/ Statistician
What You Will Learn
Panelists will discuss the importance of metadata standardization in clinical trial design & build. Hear a real-world case study from global biopharmaceutical company, UCB, as they share their experience of implementing a clinical metadata repository. This includes how this enables them to achieve their ultimate goal to automate their clinical data processes.
- How a clinical MDR (metadata repository) supports reuse and standards compliance
- Strategies for a successful MDR implementation
- How to leverage standardized content with 3rd party systems via APIs
Want to get your clinical trials designed, built & submitted faster? Now you can, with the Formedix off-the-shelf clinical metadata repository (MDR) and metadata automation platform. We’ve taken away those time-consuming and expensive manual tasks – from study set up to submission.
Our clinical MDR provides a central home for your organizational standards. Here you can manage, update, approve and reuse organizational standards, whilst keeping aligned with the relevant version of CDISC standards. You can even share and reuse content across different EDC and e-clinical systems from the Formedix platform.
And if you need help automating study design and build, Formedix can help with that too. Their clinical trial automation tools use the content in your MDR to build studies much faster. Whether you want to design eCRFs, build EDCs, design or convert datasets, or make define files… Formedix helps you do it in a fraction of the time.